MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584060

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was intended to be used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation outside the patient, it was noticed that the device was damaged.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: the cutting wire anchor was dislodged.

Manufacturer Narrative

Medical device problem code: (b)(4).The returned dreamtome rx 44 was analyzed, and a visual evaluation noted that the cutting wire anchor was dislodged from the working length.The working length was also torn.The distal section of the guidewire was slightly kinked.The device was observed under magnification, and the working length was torn from the distal pierced hole.The wire anchor was dislodged and the cutting wire was blackened.No other problems with the device were noted.The product analysis revealed that the cutting wire anchor was dislodged.Additionally, the working length was also torn.Based on the device condition, this could have been displaced the cutting wire notch from its original position (the wire anchor is outside the catheter).The condition torn working length could have been generated due to the tension forces on the catheter during handle actuation.Also, bowing the device without being completely out of the scope can lead to tear it, displacing the cutting wire notch from its position.The kinked guidewire could have been caused by operational factors, such as the user technique during insertion of the device through the scope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: DREAMTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13544284
• MDR Text Key: 287328483
• Report Number: 3005099803-2022-00789
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778288
• UDI-Public: 08714729778288
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584060
• Device Catalogue Number: 8406
• Device Lot Number: 0027116188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 58 KG